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Friday, 21 March 2014

No more OTC selling of antibiotics: new issue for schedule H1 Drugs

The
Drugs and Cosmetics Rules, 1945 (D&C rules) were amended vide Drugs
and Cosmetics (Fourth Amendment) Rules, 2013 published under Gazette
notification G.S.R. 588(E) dated 30.08.2013 regarding the inclusion of
Schedule H1 under the D&C rules containing certain antibiotics,
anti-TB drugs and habit forming drugs. The notification states that
these rules will come into force after six months of their publication
in the official Gazette i.e. from 1st March, 2014

Various
representations were received from the Drug Manufacturers Associations
and Individual manufacturers that the chemists may not be able to sell
the drugs covered under the Schedule H1 which are not labeled as per
provisions of the amended rules even though these drugs at the time of
their manufacture were labeled in accordance to the rules applicable to
them.

Ministry
of Health and Family Welfare considered all representations and it has
been decided that the drugs included in the Schedule H1 manufactured
upto 28th February, 2014 without the labeling requirements specified in
the said notification but labeled as per provisions applicable for them
at the time of their manufacture, may continue to be sold even beyond
1st March, 2014.

The
notification specifies, “The Chemist, while selling Schedule H1 drug,
would, however, be required to comply with the requirements for the sale
of drugs covered under the said notification in respect of requirements
of sale of these drugs against the prescription of an RMP and
maintenance of sale records as specified therein.”

As per Gazetted notification G.S.R. 588(E), followings are the drugs included in schedule H1 drugs: (46 drugs)